Medical Engineering Consultants (MEC)
Quality Engineer
Medical Engineering Consultants (MEC), Osseo, Minnesota, United States, 55311
Job Title: Quality Engineer – Contract (Minnesota, Locals only)
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts). MEC’s mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Onsite.
Job Purpose Develops, establishes and maintains quality engineering methodologies, systems and practices which meet our client's customer and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development operational or system/services support.
Key Responsibilities
Identify and implement effective process control systems to support the development, qualification and ongoing manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
Acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
Apply sound systematic problem‑solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Quality Systems Duties and Responsibilities Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
2-4 Years with BS
1 Year with MS
3-D printing experience required
SolidWorks experience required
CAD experience required
AAP/EEO Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts). MEC’s mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Onsite.
Job Purpose Develops, establishes and maintains quality engineering methodologies, systems and practices which meet our client's customer and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development operational or system/services support.
Key Responsibilities
Identify and implement effective process control systems to support the development, qualification and ongoing manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
Acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
Apply sound systematic problem‑solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Quality Systems Duties and Responsibilities Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
2-4 Years with BS
1 Year with MS
3-D printing experience required
SolidWorks experience required
CAD experience required
AAP/EEO Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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